Evaluation of the Farsi‐translated Hemorrhoidal Disease Symptom Score and Short Health Scale questionnaires in patients with hemorrhoid disease: A cross‐sectional study

Abstract Background and Aims The Hemorrhoidal Disease Symptom Score (HDSS) is a tool that is scored based on five main symptoms: pain, bleeding, itching, soiling, and prolapse. Furthermore, the Short Health Scale (SHS) is a measurement tool of subjective health and health‐related quality of life. This study was performed to validate the Farsi‐translated Hemorrhoidal Disease Symptom Score (HDSS), and Scale Short Health Scale adapted for hemorrhoidal disease (SHS‐HD) as a measure of symptom severity in patients with hemorrhoid disease. Methods In this study, HDSS and SHS‐HD were translated into Farsi. Participants with confirmed hemorrhoid disease completed the questionnaire. Subsequently, the questionnaire's discriminative validity, convergent validity, reliability, sensitivity, and specificity were evaluated. Results Data from 31 patients were analyzed (mean age 39.68; 71% male). The results of the analysis showed good internal consistency as Cronbach's α for HDSS and SHS were 0.994 and 0.995 respectively. Spearman's correlation coefficient for the test–retest comparison was 0.986 (p < 0.01). The responses demonstrated good convergent validity. Moreover, the comprehension and suitability of each question were rated as excellent (Pearson's correlation coefficient = 0.3). Conclusions Our findings revealed that the Farsi translation of the HDSS and SHS‐HD can be a valuable tool for evaluating the symptom severity in patients with hemorrhoid disease.


| INTRODUCTION
Hemorrhoids are defined as enlarged and displaced venous cushions within the anal canal. [1][2][3] Hemorrhoidal cushions are normal parts of the anal canal's anatomy. They play a significant role in the contraction of the anal canal at rest as they engorge with blood.
Various factors, including constipation, prolonged straining, exercise, pregnancy, obesity, aging, genetics, increased intra-abdominal pressure, valves absence within the hemorrhoidal veins, and nutrition, can lead to pathologic changes in hemorrhoid cushions and induce hemorrhoidal disease. 4,5 The most common complaints of patients suffering from the hemorrhoidal disease are bleeding, itching, soiling, prolapse, and pain. [6][7][8][9][10] Since many cases are asymptomatic and many symptomatic cases have a propensity for self-medication, the actual prevalence of hemorrhoidal disease (HD) remains unknown. 3,11,12 Nevertheless, the prevalence of hemorrhoids is reported to be 4.4% in the United States, 11% in Spain, 14.4% in Korea, 16% in Italy, and 38.93% in Austria. [9][10][11][12] Hemorrhoids are most prevalent between the ages of 45 and 65. 9 Obesity, particularly abdominal obesity, multiple pregnancies, high socioeconomic status, and white race are identified risk factors for this anorectal abnormality. 13,14 Depending on the clinical manifestations and the grade of prolapse, hemorrhoids can be managed medically or surgically. 10,15 Although the hemorrhoidal disease is not a lifethreatening condition, the disturbing symptoms can cause physical and psychological strain and impact the patient's quality of life. 6,9,13,16 Patient-Reported Outcome Measures (PROMs) can be utilized to quantify the severity of hemorrhoidal disease. 14 PROMs are patient-completed questionnaires that demonstrate the outcome or severity of symptoms from the patient's perspective. 11 Several questionnaires have been designed to assess the severity of hemorrhoids. According to a systematic review conducted in 2020 among five proposed hemorrhoid symptomspecific questionnaires, the questionnaire created by Rørvik and colleagues had acceptable standards according to the consensusbased standards for selecting health measurement instruments (COSMIN) criteria. 11,16-18 COSMIN criteria were used to assess the validity, reliability, and responsiveness of the HDSS and SHS scoring systems. 17 The HDSS is a symptom-scoring questionnaire based on the five primary symptoms of pain, bleeding, itching, soiling, and prolapse. [17][18][19][20] There is currently no disease-specific instrument for assessing health-related quality of life (HRQoL) in HD. SHS is a subjective health assessment instrument.
SHS is a simplified HRQoL evaluation technique that asks only one question for each of its four aspects: functional status, symptom load, disease-specific concerns, and overall well-being. SHS was originally developed for inflammatory bowel disease (IBD) patients; however, an HD-specific modified version focusing on hemorrhoidal disease (SHS-HD) was subsequently developed. SHS-HD is a reliable and responsive assessment instrument for HRQoL, while HDSS is a valid, reliable, and responsive measurement tool for symptoms in HD. 16 These two grading systems accurately depict a patient's symptoms and their impact on quality of life. 17,20 Translation of a prefabricated questionnaire can be challenging due to the possibility that linguistic differences and interpretations will compromise the accuracy. To assess the effectiveness, efficiency, and psychometrics of a translated questionnaire, certain statistical methods have been proposed. This study aims to translate the questionnaires to Farsi for the first time and to evaluate the validity and reliability of the Farsi translation of HDSS and SHS-HD in a colorectal center.

| Translation
After receiving permission from the original author, the questionnaire was independently translated into Farsi by four researchers fluent in both Farsi and English (forward translation). Then, they reviewed the translations to ensure that the concepts remained the same, and all inconsistencies were resolved by discussion to reach a final consensus and prepare the provisional Farsi version.

The Farsi version was then translated back into English by an
English-native colleague who was fluent in the Farsi language and was unaware of the English version (backward translation). The back-translated English version was then compared with the original to ensure no conceptual discrepancies. After the final review, the back-translated draft was emailed to the original authors for approval. Following confirmation, the Farsi version was checked for the content's simplicity, comprehensibility, and accuracy. No change was made to the final Farsi version due to the suitability of the translated content.

| Participants and data gathering
This study examined 53 consecutive patients with hemorrhoids who met the inclusion criteria and were referred to Imam Khomeini Hospital Complex in Tehran in 2020. This research also assessed the validity and psychometric weight of the Farsi translation of HDSS and SHS-HD. The study's primary findings determined the minimum sample size to be 31 cases.

| Statistical analysis
IBM SPSS AMOS (v. 26) was used for statistical analysis. p < 0.05 were considered statistically significant. scale. An impact score greater than 1.5 was deemed acceptable.

| Discriminative validity
The discriminative validity analysis of a single sample t test revealed that the HDSS and SHS scores could distinguish between older (mean age of 39.68) and younger participants (p value 0.05). However, it was unable to classify participants by gender (p = 0.574).

| Reliability
To assess the reliability of questionnaires we conducted the survey in two separate sessions; by comparing the results of the test with the retest.
The results of the analysis showed good internal consistency as Cronbach's α for HDSS and SHS were 0.994 and 0.995, respectively.
Interclass Correlation Coefficient (ICC) was calculated to be 0.997

| DISCUSSION
The present study evaluated the validity and reliability of the first  questionnaires were combined to create a 9-question form that This system can also be used to monitor the progression of disease. [20][21][22][23][24] HDSS is a symptom-scoring tool based on five main symptoms (pain, itching, bleeding, soiling, and prolapse). An SHS is a measurement tool of subjective health. SHS is a simplified HRQoL instrument with only one question in its four dimensions: functional status, symptom burden, disease-specific concerns, and general well-being.

ACKNOWLEDGMENTS
We would like to acknowledge all the contributions from the Tehran Heart Center, Tehran University of Medical Sciences. All authors have read and approved the final version of this manuscript. This study was conducted in the author's personal capacity and was not funded by any government agency; the authors themselves provided the funding.